At a glance
ClinicalIndex Comparison Record- ✓Age 12 to 24 months at time of implantation
- ✓Bilateral profound sensorineural hearing loss (250-8000 Hz)
- ✓English as primary language in the family
- ✓Minimum 3-month trial with appropriately fitted hearing aids
- ✕Medical or psychological conditions contraindicating surgery
- ✕Ossification or cochlear anomaly preventing complete electrode array insertion
- ✕Developmental disabilities or conditions preventing participation in audiological testing
- ✕Hearing loss of neural or central origin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants
In Brief
A clinical study evaluating Hybrid L24 for Implants, Cochlear and 2 related conditions. Completed, enrolled 11 participants across 2 sites.
Detailed Summary
The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. Whether or not this group of children will be able to take advantage of future hair cell regeneration strategies is yet to be determined and will have to wait for future development. At this time there are no accurate imaging strategies available to identify preservation of the scala media. Ultra thin micro CT scanning is in development, however the level of radiation delivery to the subject is too great to be considered for clinical use. When imaging strategies become available to determine cellular structure of the inner ear, they will be applied to this group of subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.
Study Details
Timeline
Interventions
Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.